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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00554346
Other study ID # 200709062M
Secondary ID
Status Completed
Phase Phase 4
First received November 4, 2007
Last updated June 20, 2010
Start date May 2008
Est. completion date June 2010

Study information

Verified date June 2010
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Post surgical pain associated with ligament reconstruction may persist for few days after the surgical procedure. Arcoxia is a new anti-inflammatory and analgesic drug that alleviate pain through oral administration. This study will test the safety and efficacy of Arcoxia in the management of post-operational pain in patients receive the ligament reconstruction surgery.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date June 2010
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender All
Age group 16 Years to 35 Years
Eligibility Inclusion Criteria:

1. Men and women age ranged from 16~35 who have anterior cruciate ligament injury and/or associated injuries are scheduled for ACL reconstruction surgery.

2. Patient agrees to participate into this study and is willing to sign the patient informed consent form.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Arcoxia(etoricoxib 90 mg/tablet)
Arcoxia(etoricoxib 90 mg/tablet) or placebo, #1, 3 days

Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (2)

Lead Sponsor Collaborator
National Taiwan University Hospital Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain at rest at different timepoint after surgical procedures From baseline(preoperation) to 3 days after